US20130020375A1 - Surgical instrument - Google Patents

Abstract

A surgical instrument. The surgical instrument has an end effector and a trigger in communication with the end effector. The surgical instrument also has a first sensor and an externally accessible memory device in communication with the first sensor. The first sensor has an output that represents a first condition of either the trigger or the end effector. The memory device is configured to record the output of the first sensor. In various embodiments, memory device may include an output port and/or a removable storage medium.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is related to the following concurrently-filed U.S. patent applications, which are incorporated herein by reference:
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH USER FEEDBACK SYSTEM
• Inventors: Frederick E. Shelton, IV, John Ouwerkerk and Jerome R. Morgan (K&LNG 050519/END5687USNP)
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK
• Inventors: Frederick E. Shelton, IV, John N. Ouwerkerk, Jerome R. Morgan, and Jeffrey S. Swayze (K&LNG 050516/END5692USNP)
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK
• Inventors: Frederick E. Shelton, IV, John N. Ouwerkerk, Jerome R. Morgan, and Jeffrey S. Swayze (K&LNG 050515/END5693USNP)
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH ADAPTIVE USER FEEDBACK
• Inventors: Frederick E. Shelton, IV, John N. Ouwerkerk, and Jerome R. Morgan (K&LNG 050513/END5694USNP)
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH ARTICULATABLE END EFFECTOR
• Inventors: Frederick E. Shelton, IV and Christoph L. Gillum (K&LNG 050692/END5769USNP)
• MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH MECHANICAL CLOSURE SYSTEM
• Inventors: Frederick E. Shelton, IV and Christoph L. Gillum (K&LNG 050693/END5770USNP)
• SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM
• Inventors: Frederick E. Shelton, IV and Kevin R. Doll (K&LNG 050694/END5771USNP)
• GEARING SELECTOR FOR A POWERED SURGICAL CUTTING AND FASTENING STAPLING INSTRUMENT
• Inventors: Frederick E. Shelton, IV, Jeffrey S. Swayze, Eugene L. Timperman (K&LNG 050697/END5772USNP)
• SURGICAL INSTRUMENT HAVING A REMOVABLE BATTERY
• Inventors: Frederick E. Shelton, IV, Kevin R. Doll, Jeffrey S. Swayze and Eugene Timperman (K&LNG 050699/END5774USNP)
• ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENT INCLUDING SAME
• Inventors: Jeffrey S. Swayze, Frederick E. Shelton, IV, Kevin R. Doll (K&LNG 050700/END5775USNP)
• ENDOSCOPIC SURGICAL INSTRUMENT WITH A HANDLE THAT CAN ARTICULATE WITH RESPECT TO THE SHAFT
• Inventors: Frederick E. Shelton, IV, Jeffrey S. Swayze, Mark S. Ortiz, and Leslie M. Fugikawa (K&LNG 050701/END5776USNP)
• ELECTRO-MECHANICAL SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING A ROTARY FIRING AND CLOSURE SYSTEM WITH PARALLEL CLOSURE AND ANVIL ALIGNMENT COMPONENTS
• Inventors: Frederick E. Shelton, IV, Stephen J. Balek and Eugene L. Timperman (K&LNG 050702/END5777USNP)
• DISPOSABLE STAPLE CARTRIDGE HAVING AN ANVIL WITH TISSUE LOCATOR FOR USE WITH A SURGICAL CUTTING AND FASTENING INSTRUMENT AND MODULAR END EFFECTOR SYSTEM THEREFOR
• Inventors: Frederick E. Shelton, IV, Michael S. Cropper, Joshua M. Broehl, Ryan S. Crisp, Jamison J. Float, Eugene L. Timperman (K&LNG 050703/END5778USNP)
• SURGICAL INSTRUMENT HAVING A FEEDBACK SYSTEM
• Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Kevin R. Doll, Jeffrey S. Swayze and Eugene Timperman (K&LNG 050705/EDN5780USNP)
BACKGROUND
• The present invention relates in general to surgical instruments, and more particularly to minimally invasive surgical instruments capable of recording various conditions of the instrument.
• Endoscopic surgical instruments are often preferred over traditional open surgical devices because a smaller incision tends to reduce the post-operative recovery time and complications. Consequently, significant development has gone into a range of endoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.).
• Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision. The end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil.
• An example of a surgical stapler suitable for endoscopic applications is described in U.S. Pat. No. 5,465,895, entitled “SURGICAL STAPLER INSTRUMENT” to Knodel et al., which discloses an endocutter with distinct closing and firing actions. A clinician using this device is able to close the jaw members upon tissue to position the tissue prior to firing. Once the clinician has determined that the jaw members are properly gripping tissue, the clinician can then fire the surgical stapler with a single firing stroke, or multiple firing strokes, depending on the device. Firing the surgical stapler causes severing and stapling of the tissue. The simultaneous severing and stapling avoids complications that may arise when performing such actions sequentially with different surgical tools that respectively only sever and staple.
• One specific advantage of being able to close upon tissue before firing is that the clinician is able to verify via an endoscope that the desired location for the cut has been achieved, including a sufficient amount of tissue has been captured between opposing jaws. Otherwise, opposing jaws may be drawn too close together, especially pinching at their distal ends, and thus not effectively forming closed staples in the severed tissue. At the other extreme, an excessive amount of clamped tissue may cause binding and an incomplete firing.
• When endoscopic surgical instruments fail, they are often returned to the manufacturer, or other entity, for analysis of the failure. If the failure resulted in a critical class of defect in the instrument, it is necessary for the manufacturer to determine the cause of the failure and determine whether a design change is required. In that case, the manufacturer may spend many hundreds of man-hours analyzing a failed instrument and attempting to reconstruct the conditions under which it failed based only on the damage to the instrument. It can be expensive and very challenging to analyze instrument failures in this way. Also, many of these analyses simply conclude that the failure was due to improper use of the instrument.
SUMMARY
• In one general aspect, the present invention is directed to a surgical instrument. The surgical instrument has an end effector and a trigger in communication with the end effector. The surgical instrument also has a first sensor and an externally accessible memory device in communication with the first sensor. The first sensor has an output that represents a first condition of either the trigger or the end effector. The memory device is configured to record the output of the first sensor. In various embodiments, memory device may include an output port and/or a removable storage medium.
• Also, in various embodiments, the output of the first sensor represents a condition of the end effector and the instrument further comprises a second sensor with an output representing a condition of the trigger. The memory device is configured to record the output of the first sensor and the second sensor.
• In another general aspect, the present invention is directed to a method of recording the state of a surgical instrument. The method comprises the step of monitoring outputs of a plurality of sensors. The outputs represent conditions of the surgical instrument. The method also comprises the step of recording the outputs to a memory device when at least one of the conditions of the surgical instrument changes. In various embodiments, the method may also comprise the step of providing the recorded outputs of the plurality of sensors to an outside device.
DRAWINGS
• Various embodiments of the present invention are described herein by way of example in conjunction with the following figures, wherein
• FIGS. 1 and 2 are perspective views of a surgical cutting and fastening instrument according to various embodiments of the present invention;
• FIGS. 3-5 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention;
• FIG. 6 is a side view of the end effector according to various embodiments of the present invention;
• FIG. 7 is an exploded view of the handle of the instrument according to various embodiments of the present invention;
• FIGS. 8 and 9 are partial perspective views of the handle according to various embodiments of the present invention;
• FIG. 10 is a side view of the handle according to various embodiments of the present invention;
• FIGS. 10A and 10B illustrate a proportional sensor that may be used according to various embodiments of the present invention;
• FIG. 11 is a schematic diagram of a circuit used in the instrument according to various embodiments of the present invention;
• FIGS. 12-13 are side views of the handle according to other embodiments of the present invention;
• FIGS. 14-22 illustrate different mechanisms for locking the closure trigger according to various embodiments of the present invention;
• FIGS. 23A-B show a universal joint (“u-joint”) that may be employed at the articulation point of the instrument according to various embodiments of the present invention;
• FIGS. 24A-B shows a torsion cable that may be employed at the articulation point of the instrument according to various embodiments of the present invention;
• FIGS. 25-31 illustrate a surgical cutting and fastening instrument with power assist according to another embodiment of the present invention;
• FIGS. 32-36 illustrate a surgical cutting and fastening instrument with power assist according to yet another embodiment of the present invention;
• FIGS. 37-40 illustrate a surgical cutting and fastening instrument with tactile feedback to embodiments of the present invention;
• FIG. 41 illustrates an exploded view of an end effector and shaft of the instrument according to various embodiments of the present invention;
• FIG. 42 illustrates a side view of the handle of a mechanically instrument according to various embodiments of the present invention;
• FIG. 43 illustrates an exploded view of the handle of the mechanically actuated instrument ofFIG. 42;
• FIG. 44 illustrates a block diagram of a recording system for recording various conditions of the instrument according to various embodiments of the present invention;
• FIGS. 45-46 illustrate cut away side views of a handle of the instrument showing various sensors according to various embodiments of the present invention;
• FIG. 47 illustrates the end effector of the instrument showing various sensors according to various embodiments of the present invention;
• FIG. 48 illustrates a firing bar of the instrument including a sensor according to various embodiments of the present invention;
• FIG. 49 illustrates a side view of the handle, end effector, and firing bar of the instrument showing a sensor according to various embodiments of the present invention;
• FIG. 50 illustrates an exploded view of the staple channel and portions of a staple cartridge of the instrument showing various sensors according to various embodiments of the present invention;
• FIG. 51 illustrates a top down view of the staple channel of the instrument showing various sensors according to various embodiments of the present invention;
• FIGS. 52A and 52B illustrate a flow chart showing a method for operating the instrument according to various embodiments; and
• FIG. 53 illustrates a memory chart showing exemplary recorded conditions of the instrument according to various embodiments of the present invention.
DETAILED DESCRIPTION
• FIGS. 1 and 2 depict a surgical cutting andfastening instrument10 according to various embodiments of the present invention. The illustrated embodiment is an endoscopicsurgical instrument10 and in general, the embodiments of theinstrument10 described herein are endoscopic surgical cutting and fastening instruments. It should be noted, however, that according to other embodiments of the present invention, theinstrument10 may be a non-endoscopic surgical cutting instrument, such as a laproscopic instrument.
• Thesurgical instrument10 depicted inFIGS. 1 and 2 comprises ahandle6, ashaft8, and an articulatingend effector12 pivotally connected to theshaft8 at anarticulation pivot14. Anarticulation control16 may be provided adjacent to thehandle6 to effect rotation of theend effector12 about thearticulation pivot14. It will be appreciated that various embodiments may include a non-pivoting end effector, and therefore may not have anarticulation pivot14 orarticulation control16. Also, in the illustrated embodiment, theend effector12 is configured to act as an endocutter for clamping, severing and stapling tissue, although, in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc.
• Thehandle6 of theinstrument10 may include aclosure trigger18 and a firingtrigger20 for actuating theend effector12. It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating theend effector12. Theend effector12 is shown separated from thehandle6 by a preferablyelongate shaft8. In one embodiment, a clinician or operator of theinstrument10 may articulate theend effector12 relative to theshaft8 by utilizing thearticulation control16, as described in more detail in pending U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled “Surgical Instrument Having An Articulating End Effector,” by Geoffrey C. Hueil et al., which is incorporated herein by reference.
• Theend effector12 includes in this example, among other things, astaple channel22 and a pivotally translatable clamping member, such as ananvil24, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector12. Thehandle6 includes apistol grip26 toward which aclosure trigger18 is pivotally drawn by the clinician to cause clamping or closing of theanvil24 towards thestaple channel22 of theend effector12 to thereby clamp tissue positioned between theanvil24 andchannel22. The firingtrigger20 is farther outboard of theclosure trigger18. Once theclosure trigger18 is locked in the closure position as further described below, the firingtrigger20 may rotate slightly toward thepistol grip26 so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firingtrigger20 toward thepistol grip26 to cause the stapling and severing of clamped tissue in theend effector12. In other embodiments, different types of clamping members besides theanvil24 could be used, such as, for example, an opposing jaw, etc.
• It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping thehandle6 of aninstrument10. Thus, theend effector12 is distal with respect to the moreproximal handle6. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
• Theclosure trigger18 may be actuated first. Once the clinician is satisfied with the positioning of theend effector12, the clinician may draw back theclosure trigger18 to its fully closed, locked position proximate to thepistol grip26. The firingtrigger20 may then be actuated. The firingtrigger20 returns to the open position (shown inFIGS. 1 and 2) when the clinician removes pressure, as described more fully below. A release button on thehandle6, when depressed may release the lockedclosure trigger18. The release button may be implemented in various forms such as, for example,release button30 shown inFIGS. 42-43,slide release button160 shown inFIG. 14, and/orbutton172 shown inFIG. 16.
• FIGS. 3-6 show embodiments of a rotary-drivenend effector12 andshaft8 according to various embodiments.FIG. 3 is an exploded view of theend effector12 according to various embodiments. As shown in the illustrated embodiment, theend effector12 may include, in addition to the previously-mentionedchannel22 andanvil24, a cuttinginstrument32, asled33, astaple cartridge34 that is removably seated in thechannel22, and ahelical screw shaft36. The cuttinginstrument32 may be, for example, a knife Theanvil24 may be pivotably opened and closed at pivot pins25 connected to the proximate end of thechannel22. Theanvil24 may also include atab27 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil24. When theclosure trigger18 is actuated, that is, drawn in by a user of theinstrument10, theanvil24 may pivot about the pivot pins25 into the clamped or closed position. If clamping of theend effector12 is satisfactory, the operator may actuate the firingtrigger20, which, as explained in more detail below, causes theknife32 andsled33 to travel longitudinally along thechannel22, thereby cutting tissue clamped within theend effector12. The movement of thesled33 along thechannel22 causes the staples (not shown) of thestaple cartridge34 to be driven through the severed tissue and against theclosed anvil24, which turns the staples to fasten the severed tissue. In various embodiments, thesled33 may be an integral component of thecartridge34. U.S. Pat. No. 6,978,921, entitled “SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM” to Shelton, IV et al., which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. Thesled33 may be part of thecartridge34, such that when theknife32 retracts following the cutting operation, thesled33 does not retract.
• It should be noted that although the embodiments of theinstrument10 described herein employ anend effector12 that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680, entitled “ELECTROSURGICAL HEMOSTATIC DEVICE” to Yates et al., and U.S. Pat. No. 5,688,270 entitled “ELECTOSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSET ELECTRODES” to Yates et al. which are incorporated herein by reference, disclose an endoscopic cutting instrument that uses RF energy to seal the severed tissue. U.S. patent application Ser. No. 11/267,811 to Jerome R. Morgan, et. al, and U.S. patent application Ser. No. 11/267,383 to Frederick E. Shelton, IV, et. al, which are also incorporated herein by reference, disclose cutting instruments that uses adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like below, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue fastening techniques may also be used.
• FIGS. 4 and 5 are exploded views andFIG. 6 is a side view of theend effector12 andshaft8 according to various embodiments. As shown in the illustrated embodiment, theshaft8 may include aproximate closure tube40 and adistal closure tube42 pivotably linked by apivot link44. Thedistal closure tube42 includes anopening45 into which thetab27 on theanvil24 is inserted in order to open and close theanvil24, as further described below. Disposed inside theclosure tubes40,42 may be aproximate spine tube46. Disposed inside theproximate spine tube46 may be a main rotational (or proximate) driveshaft48 that communicates with a secondary (or distal) driveshaft50 via a bevel gear assembly52. Thesecondary drive shaft50 is connected to adrive gear54 that engages aproximate drive gear56 of thehelical screw shaft36. Thevertical bevel gear52bmay sit and pivot in anopening57 in the distal end of theproximate spine tube46. Adistal spine tube58 may be used to enclose thesecondary drive shaft50 and the drive gears54,56. Collectively, themain drive shaft48, thesecondary drive shaft50, and the articulation assembly (e.g., the bevel gear assembly52a-c) are sometimes referred to herein as the “main drive shaft assembly.”
• Abearing38, positioned at a distal end of thestaple channel22, receives thehelical drive screw36, allowing thehelical drive screw36 to freely rotate with respect to thechannel22. Thehelical screw shaft36 may interface a threaded opening (not shown) of theknife32 such that rotation of theshaft36 causes theknife32 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel22. Accordingly, when themain drive shaft48 is caused to rotate by actuation of the firing trigger20 (as explained in more detail below), the bevel gear assembly52a-ccauses thesecondary drive shaft50 to rotate, which in turn, because of the engagement of the drive gears54,56, causes thehelical screw shaft36 to rotate, which causes theknife driving member32 to travel longitudinally along thechannel22 to cut any tissue clamped within theend effector12. Thesled33 may be made of, for example, plastic, and may have a sloped distal surface. As thesled33 traverses thechannel22, the sloped forward surface may push up or drive the staples in the staple cartridge through the clamped tissue and against theanvil24. Theanvil24 turns the staples, thereby stapling the severed tissue. When theknife32 is retracted, theknife32 andsled33 may become disengaged, thereby leaving thesled33 at the distal end of thechannel22.
• As described above, because of the lack of user feedback for the cutting/stapling operation, there is a general lack of acceptance among physicians of motor-driven endocutters where the cutting/stapling operation is actuated by merely pressing a button. In contrast, embodiments of the present invention provide a motor-driven endocutter with user-feedback of the deployment, force and/or position of the cuttinginstrument32 inend effector12.
• FIGS. 7-10 illustrate an exemplary embodiment of a motor-driven endocutter, and in particular the handle thereof, that provides user-feedback regarding the deployment and loading force of the cuttinginstrument32 in theend effector12. In addition, the embodiment may use power provided by the user in retracting the firingtrigger20 to power the device (a so-called “power assist” mode). The embodiment may be used with the rotary drivenend effector12 andshaft8 embodiments described above. As shown in the illustrated embodiment, thehandle6 includes exteriorlower side pieces59,60 and exteriorupper side pieces61,62 that fit together to form, in general, the exterior of thehandle6. Abattery64, such as a Li ion battery, may be provided in thepistol grip portion26 of thehandle6. Thebattery64 powers amotor65 disposed in an upper portion of thepistol grip portion26 of thehandle6. According to various embodiments, themotor65 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 RPM. Themotor65 may drive a 90°bevel gear assembly66 comprising afirst bevel gear68 and asecond bevel gear70. Thebevel gear assembly66 may drive aplanetary gear assembly72. Theplanetary gear assembly72 may include apinion gear74 connected to adrive shaft76. Thepinion gear74 may drive amating ring gear78 that drives ahelical gear drum80 via adrive shaft82. Aring84 may be threaded on thehelical gear drum80. Thus, when themotor65 rotates, thering84 is caused to travel along thehelical gear drum80 by means of the interposedbevel gear assembly66,planetary gear assembly72 andring gear78.
• Thehandle6 may also include a run motor sensor110 (seeFIG. 10) in communication with the firingtrigger20 to detect when the firingtrigger20 has been drawn in (or “closed”) toward thepistol grip portion26 of thehandle6 by the operator to thereby actuate the cutting/stapling operation by theend effector12. Thesensor110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firingtrigger20 is drawn in, thesensor110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor65. When thesensor110 is a variable resistor or the like, the rotation of themotor65 may be generally proportional to the amount of movement of the firingtrigger20. That is, if the operator only draws or closes the firingtrigger20 in a little bit, the rotation of themotor65 is relatively low. When the firingtrigger20 is fully drawn in (or in the fully closed position), the rotation of themotor65 is at its maximum. In other words, the harder the user pulls on the firingtrigger20, the more voltage is applied to themotor65, causing greater rates of rotation.
• Thehandle6 may include amiddle handle piece104 adjacent to the upper portion of the firingtrigger20. Thehandle6 also may comprise abias spring112 connected between posts on themiddle handle piece104 and the firingtrigger20. Thebias spring112 may bias the firingtrigger20 to its fully open position. In that way, when the operator releases the firingtrigger20, thebias spring112 will pull the firingtrigger20 to its open position, thereby removing actuation of thesensor110, thereby stopping rotation of themotor65. Moreover, by virtue of thebias spring112, any time a user closes the firingtrigger20, the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by themotor65. Further, the operator could stop retracting the firingtrigger20 to thereby remove force from thesensor100, to thereby stop themotor65. As such, the user may stop the deployment of theend effector12, thereby providing a measure of control of the cutting/fastening operation to the operator.
• The distal end of thehelical gear drum80 includes adistal drive shaft120 that drives aring gear122, which mates with apinion gear124. Thepinion gear124 is connected to themain drive shaft48 of the main drive shaft assembly. In that way, rotation of themotor65 causes the main drive shaft assembly to rotate, which causes actuation of theend effector12, as described above.
• Thering84 threaded on thehelical gear drum80 may include apost86 that is disposed within aslot88 of a slottedarm90. The slottedarm90 has an opening92 itsopposite end94 that receives apivot pin96 that is connected between the handleexterior side pieces59,60. Thepivot pin96 is also disposed through anopening100 in the firingtrigger20 and anopening102 in themiddle handle piece104.
• In addition, thehandle6 may include a reverse motor sensor (or end-of-stroke sensor)130 and a stop motor (or beginning-of-stroke)sensor142. In various embodiments, thereverse motor sensor130 may be a limit switch located at the distal end of thehelical gear drum80 such that thering84 threaded on thehelical gear drum80 contacts and trips thereverse motor sensor130 when thering84 reaches the distal end of thehelical gear drum80. Thereverse motor sensor130, when activated, sends a signal to themotor65 to reverse its rotation direction, thereby withdrawing theknife32 of theend effector12 following the cutting operation.
• Thestop motor sensor142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum80 so that thering84 trips theswitch142 when thering84 reaches the proximate end of thehelical gear drum80.
• In operation, when an operator of theinstrument10 pulls back the firingtrigger20, thesensor110 detects the deployment of the firingtrigger20 and sends a signal to themotor65 to cause forward rotation of themotor65, for example, at a rate proportional to how hard the operator pulls back the firingtrigger20. The forward rotation of themotor65 in turn causes thering gear78 at the distal end of theplanetary gear assembly72 to rotate, thereby causing thehelical gear drum80 to rotate, causing thering84 threaded on thehelical gear drum80 to travel distally along thehelical gear drum80. The rotation of thehelical gear drum80 also drives the main drive shaft assembly as described above, which in turn causes deployment of theknife32 in theend effector12. That is, theknife32 andsled33 are caused to traverse thechannel22 longitudinally, thereby cutting tissue clamped in theend effector12. Also, the stapling operation of theend effector12 is caused to happen in embodiments where a stapling-type end effector12 is used.
• By the time the cutting/stapling operation of theend effector12 is complete, thering84 on thehelical gear drum80 will have reached the distal end of thehelical gear drum80, thereby causing thereverse motor sensor130 to be tripped, which sends a signal to themotor65 to cause themotor65 to reverse its rotation. This in turn causes theknife32 to retract, and also causes thering84 on thehelical gear drum80 to move back to the proximate end of thehelical gear drum80.
• Themiddle handle piece104 includes abackside shoulder106 that engages the slottedarm90 as best shown inFIGS. 8 and 9. Themiddle handle piece104 also has a forward motion stop107 that engages the firingtrigger20. The movement of the slottedarm90 is controlled, as explained above, by rotation of themotor65. When the slottedarm90 rotates counter clockwise as thering84 travels from the proximate end of thehelical gear drum80 to the distal end, themiddle handle piece104 will be free to rotate counter clockwise. Thus, as the user draws in the firingtrigger20, the firingtrigger20 will engage the forward motion stop107 of themiddle handle piece104, causing themiddle handle piece104 to rotate counter clockwise. Due to thebackside shoulder106 engaging the slottedarm90, however, themiddle handle piece104 will only be able to rotate counter clockwise as far as the slottedarm90 permits. In that way, if themotor65 should stop rotating for some reason, the slottedarm90 will stop rotating, and the user will not be able to further draw in the firingtrigger20 because themiddle handle piece104 will not be free to rotate counter clockwise due to the slottedarm90.
• FIGS. 10A and 10B illustrate two states of a variable sensor that may be used as therun motor sensor110 according to various embodiments of the present invention. Thesensor110 may include aface portion280, a first electrode (A)282, a second electrode (B)284, and a compressibledielectric material286 between theelectrodes282,284, such as, for example, an electoactive polymer (EAP). Thesensor110 may be positioned such that theface portion280 contacts the firingtrigger20 when retracted. Accordingly, when the firingtrigger20 is retracted, thedielectric material286 is compressed, as shown inFIG. 10B, such that theelectrodes282,284 are closer together. Since the distance “b” between theelectrodes282,284 is directly related to the impedance between theelectrodes282,284, the greater the distance the more impedance, and the closer the distance the less impedance. In that way, the amount that the dielectric286 is compressed due to retraction of the firing trigger20 (denoted as force “F” inFIG. 42) is proportional to the impedance between theelectrodes282,284, which can be used to proportionally control themotor65.
• Components of an exemplary closure system for closing (or clamping) theanvil24 of theend effector12 by retracting theclosure trigger18 are also shown inFIGS. 7-10. In the illustrated embodiment, the closure system includes ayoke250 connected to theclosure trigger18 by apivot pin251 inserted through aligned openings in both theclosure trigger18 and theyoke250. Apivot pin252, about which theclosure trigger18 pivots, is inserted through another opening in theclosure trigger18 which is offset from where thepin251 is inserted through theclosure trigger18. Thus, retraction of theclosure trigger18 causes the upper part of theclosure trigger18, to which theyoke250 is attached via thepin251, to rotate counterclockwise. The distal end of theyoke250 is connected, via apin254, to afirst closure bracket256. Thefirst closure bracket256 connects to asecond closure bracket258. Collectively, theclosure brackets256,258 define an opening in which the proximate end of the proximate closure tube40 (seeFIG. 4) is seated and held such that longitudinal movement of theclosure brackets256,258 causes longitudinal motion by theproximate closure tube40. Theinstrument10 also includes aclosure rod260 disposed inside theproximate closure tube40. Theclosure rod260 may include awindow261 into which apost263 on one of the handle exterior pieces, such as exteriorlower side piece59 in the illustrated embodiment, is disposed to fixedly connect theclosure rod260 to thehandle6. In that way, theproximate closure tube40 is capable of moving longitudinally relative to theclosure rod260. Theclosure rod260 may also include adistal collar267 that fits into acavity269 inproximate spine tube46 and is retained therein by a cap271 (seeFIG. 4).
• In operation, when theyoke250 rotates due to retraction of theclosure trigger18, theclosure brackets256,258 cause theproximate closure tube40 to move distally (i.e., away from the handle end of the instrument10), which causes thedistal closure tube42 to move distally, which causes theanvil24 to rotate about the pivot pins25 into the clamped or closed position. When theclosure trigger18 is unlocked from the locked position, theproximate closure tube40 is caused to slide proximately, which causes thedistal closure tube42 to slide proximately, which, by virtue of thetab27 being inserted in thewindow45 of thedistal closure tube42, causes theanvil24 to pivot about the pivot pins25 into the open or unclamped position. In that way, by retracting and locking theclosure trigger18, an operator may clamp tissue between theanvil24 andchannel22, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger20 from the locked position.
• FIG. 11 is a schematic diagram of an electrical circuit of theinstrument10 according to various embodiments of the present invention. When an operator initially pulls in the firingtrigger20 after locking theclosure trigger18, thesensor110 is activated, allowing current to flow there through. If the normally-open reversemotor sensor switch130 is open (meaning the end of the end effector stroke has not been reached), current will flow to a single pole,double throw relay132. Since the reversemotor sensor switch130 is not closed, theinductor134 of therelay132 will not be energized, so therelay132 will be in its non-energized state. The circuit also includes acartridge lockout sensor136. If theend effector12 includes astaple cartridge34, thesensor136 will be in the closed state, allowing current to flow. Otherwise, if theend effector12 does not include astaple cartridge34, thesensor136 will be open, thereby preventing thebattery64 from powering themotor65.
• When thestaple cartridge34 is present, thesensor136 is closed, which energizes a single pole,single throw relay138. When therelay138 is energized, current flows through therelay136, through thevariable resistor sensor110, and to themotor65 via a double pole,double throw relay140, thereby powering themotor65 and allowing it to rotate in the forward direction.
• When theend effector12 reaches the end of its stroke, thereverse motor sensor130 will be activated, thereby closing theswitch130 and energizing therelay134. This causes therelay134 to assume its energized state (not shown inFIG. 13), which causes current to bypass thecartridge lockout sensor136 andvariable resistor110, and instead causes current to flow to both the normally-closed double pole,double throw relay142 and back to themotor65, but in a manner, via therelay140, that causes themotor65 to reverse its rotational direction.
• Because the stopmotor sensor switch142 is normally-closed, current will flow back to therelay134 to keep it closed until theswitch142 opens. When theknife32 is fully retracted, the stopmotor sensor switch142 is activated, causing theswitch142 to open, thereby removing power from themotor65.
• In other embodiments, rather than a proportional-type sensor110, an on-off type sensor could be used. In such embodiments, the rate of rotation of themotor65 would not be proportional to the force applied by the operator. Rather, themotor65 would generally rotate at a constant rate. But the operator would still experience force feedback because the firingtrigger20 is geared into the gear drive train.
• FIG. 12 is a side-view of thehandle6 of a power-assist motorized endocutter according to another embodiment. The embodiment ofFIG. 12 is similar to that ofFIGS. 7-10 except that in the embodiment ofFIG. 12, there is no slotted arm connected to thering84 threaded on thehelical gear drum80. Instead, in the embodiment ofFIG. 12, thering84 includes asensor portion114 that moves with thering84 as thering84 advances down (and back) on thehelical gear drum80. Thesensor portion114 includes anotch116. Thereverse motor sensor130 may be located at the distal end of thenotch116 and thestop motor sensor142 may be located at the proximate end of thenotch116. As thering84 moves down the helical gear drum80 (and back), thesensor portion114 moves with it. Further, as shown inFIG. 12, themiddle piece104 may have an arm118 that extends into thenotch12.
• In operation, as an operator of theinstrument10 retracts in the firingtrigger20 toward thepistol grip26, therun motor sensor110 detects the motion and sends a signal to power themotor65, which causes, among other things, thehelical gear drum80 to rotate. As thehelical gear drum80 rotates, thering84 threaded on thehelical gear drum80 advances (or retracts, depending on the rotation). Also, due to the pulling in of the firingtrigger20, themiddle piece104 is caused to rotate counter clockwise with the firingtrigger20 due to the forward motion stop107 that engages the firingtrigger20. The counter clockwise rotation of themiddle piece104 cause the arm118 to rotate counter clockwise with thesensor portion114 of thering84 such that the arm118 stays disposed in thenotch116. When thering84 reaches the distal end of thehelical gear drum80, the arm118 will contact and thereby trip thereverse motor sensor130. Similarly, when thering84 reaches the proximate end of thehelical gear drum80, the arm will contact and thereby trip thestop motor sensor142. Such actions may reverse and stop themotor65, respectively as described above.
• FIG. 13 is a side-view of thehandle6 of a power-assist motorized endocutter according to another embodiment. The embodiment ofFIG. 13 is similar to that ofFIGS. 7-10 except that in the embodiment ofFIG. 13, there is no slot in theArm90. Instead, thering84 threaded on thehelical gear drum80 includes avertical channel126. Instead of a slot, thearm90 includes apost128 that is disposed in thechannel126. As thehelical gear drum80 rotates, thering84 threaded on thehelical gear drum80 advances (or retracts, depending on the rotation). Thearm90 rotates counter clockwise as thering84 advances due to thepost128 being disposed in thechannel126, as shown inFIG. 13.
• As mentioned above, in using a two-stroke motorized instrument, the operator first pulls back and locks theclosure trigger18.FIGS. 14 and 15 show one embodiment of a way to lock theclosure trigger18 to thepistol grip portion26 of thehandle6. In the illustrated embodiment, thepistol grip portion26 includes ahook150 that is biased to rotate counter clockwise about apivot point151 by atorsion spring152. Also, theclosure trigger18 includes aclosure bar154. As the operator draws in theclosure trigger18, theclosure bar154 engages a slopedportion156 of thehook150, thereby rotating thehook150 upward (or clockwise inFIGS. 14-15) until theclosure bar154 completely passes the slopedportion156 passes into a recessednotch158 of thehook150, which locks theclosure trigger18 in place. The operator may release theclosure trigger18 by pushing down on aslide button release160 on the back or opposite side of thepistol grip portion26. Pushing down theslide button release160 rotates thehook150 clockwise such that theclosure bar154 is released from the recessednotch158.
• FIG. 16 shows another closure trigger locking mechanism according to various embodiments. In the embodiment ofFIG. 16, theclosure trigger18 includes awedge160 having an arrow-head portion161. The arrow-head portion161 is biased downward (or clockwise) by aleaf spring162. Thewedge160 andleaf spring162 may be made from, for example, molded plastic. When theclosure trigger18 is retracted, the arrow-head portion161 is inserted through anopening164 in thepistol grip portion26 of thehandle6. Alower chamfered surface166 of the arrow-head portion161 engages alower sidewall168 of theopening164, forcing the arrow-head portion161 to rotate counter clockwise. Eventually thelower chamfered surface166 fully passes thelower sidewall168, removing the counter clockwise force on the arrow-head portion161, causing thelower sidewall168 to slip into a locked position in anotch170 behind the arrow-head portion161.
• To unlock theclosure trigger18, a user presses down on abutton172 on the opposite side of theclosure trigger18, causing the arrow-head portion161 to rotate counter clockwise and allowing the arrow-head portion161 to slide out of theopening164.
• FIGS. 17-22 show a closure trigger locking mechanism according to another embodiment. As shown in this embodiment, theclosure trigger18 includes a flexiblelongitudinal arm176 that includes alateral pin178 extending therefrom. Thearm176 and pin178 may be made from molded plastic, for example. Thepistol grip portion26 of thehandle6 includes anopening180 with a laterally extendingwedge182 disposed therein. When theclosure trigger18 is retracted, thepin178 engages thewedge182, and thepin178 is forced downward (i.e., thearm176 is rotated clockwise) by thelower surface184 of thewedge182, as shown inFIGS. 17 and 18. When thepin178 fully passes thelower surface184, the clockwise force on thearm176 is removed, and thepin178 is rotated counter clockwise such that thepin178 comes to rest in anotch186 behind thewedge182, as shown inFIG. 19, thereby locking theclosure trigger18. Thepin178 is further held in place in the locked position by aflexible stop188 extending from thewedge184.
• To unlock theclosure trigger18, the operator may further squeeze theclosure trigger18, causing thepin178 to engage asloped backwall190 of theopening180, forcing thepin178 upward past theflexible stop188, as shown inFIGS. 20 and 21. Thepin178 is then free to travel out anupper channel192 in theopening180 such that theclosure trigger18 is no longer locked to thepistol grip portion26, as shown inFIG. 22.
• FIGS. 23A-B show a universal joint (“u joint”)195. The second piece195-2 of the u-joint195 rotates in a horizontal plane in which the first piece195-1 lies.FIG. 23A shows the u-joint195 in a linear (180°) orientation andFIG. 23B shows the u-joint195 at approximately a 150° orientation. The u-joint195 may be used instead of the bevel gears52a-c(seeFIG. 4, for example) at thearticulation point14 of the main drive shaft assembly to articulate theend effector12.FIGS. 24A-B show atorsion cable197 that may be used in lieu of both the bevel gears52a-cand the u-joint195 to realize articulation of theend effector12.
• FIGS. 25-31 illustrate another embodiment of a motorized, two-stroke surgical cutting andfastening instrument10 with power assist according to another embodiment of the present invention. The embodiment ofFIGS. 25-31 is similar to that ofFIGS. 6-10 except that instead of thehelical gear drum80, the embodiment ofFIGS. 23-28 includes an alternative gear drive assembly. The embodiment ofFIGS. 25-31 includes agear box assembly200 including a number of gears disposed in aframe201, wherein the gears are connected between theplanetary gear72 and thepinion gear124 at the proximate end of thedrive shaft48. As explained further below, thegear box assembly200 provides feedback to the user via the firingtrigger20 regarding the deployment and loading force of theend effector12. Also, the user may provide power to the system via thegear box assembly200 to assist the deployment of theend effector12. In that sense, like the embodiments described above, the embodiment ofFIGS. 23-32 is another power assistmotorized instrument10 that provides feedback to the user regarding the loading force experienced by the instrument.
• In the illustrated embodiment, the firingtrigger20 includes two pieces: amain body portion202 and astiffening portion204. Themain body portion202 may be made of plastic, for example, and the stiffeningportion204 may be made out of a more rigid material, such as metal. In the illustrated embodiment, the stiffeningportion204 is adjacent to themain body portion202, but according to other embodiments, the stiffeningportion204 could be disposed inside themain body portion202. Apivot pin207 may be inserted through openings in the firingtrigger pieces202,204 and may be the point about which the firingtrigger20 rotates. In addition, aspring222 may bias the firingtrigger20 to rotate in a counter clockwise direction. Thespring222 may have a distal end connected to apin224 that is connected to thepieces202,204 of the firingtrigger20. The proximate end of thespring222 may be connected to one of the handle exteriorlower side pieces59,60.
• In the illustrated embodiment, both themain body portion202 and the stiffeningportion204 includesgear portions206,208 (respectively) at their upper end portions. Thegear portions206,208 engage a gear in thegear box assembly200, as explained below, to drive the main drive shaft assembly and to provide feedback to the user regarding the deployment of theend effector12.
• Thegear box assembly200 may include as shown, in the illustrated embodiment, six (6) gears. Afirst gear210 of thegear box assembly200 engages thegear portions206,208 of the firingtrigger20. In addition, thefirst gear210 engages a smallersecond gear212, the smallersecond gear212 being coaxial with a largethird gear214. Thethird gear214 engages a smallerfourth gear216, the smaller fourth gear being coaxial with afifth gear218. Thefifth gear218 is a 90° bevel gear that engages amating 90° bevel gear220 (best shown inFIG. 31) that is connected to thepinion gear124 that drives themain drive shaft48.
• In operation, when the user retracts the firingtrigger20, a run motor sensor (not shown) is activated, which may provide a signal to themotor65 to rotate at a rate proportional to the extent or force with which the operator is retracting the firingtrigger20. This causes themotor65 to rotate at a speed proportional to the signal from the sensor. The sensor is not shown for this embodiment, but it could be similar to therun motor sensor110 described above. The sensor could be located in thehandle6 such that it is depressed when the firingtrigger20 is retracted. Also, instead of a proportional-type sensor, an on/off type sensor may be used.
• Rotation of themotor65 causes the bevel gears68,70 to rotate, which causes theplanetary gear72 to rotate, which causes, via thedrive shaft76, thering gear122 to rotate. Thering gear122 meshes with thepinion gear124, which is connected to themain drive shaft48. Thus, rotation of thepinion gear124 drives themain drive shaft48, which causes actuation of the cutting/stapling operation of theend effector12.
• Forward rotation of thepinion gear124 in turn causes thebevel gear220 to rotate, which causes, by way of the rest of the gears of thegear box assembly200, thefirst gear210 to rotate. Thefirst gear210 engages thegear portions206,208 of the firingtrigger20, thereby causing the firingtrigger20 to rotate counter clockwise when themotor65 provides forward drive for the end effector12 (and to rotate counter clockwise when themotor65 rotates in reverse to retract the end effector12). In that way, the user experiences feedback regarding loading force and deployment of theend effector12 by way of the user's grip on the firingtrigger20. Thus, when the user retracts the firingtrigger20, the operator will experience a resistance related to the load force experienced by theend effector12. Similarly, when the operator releases the firingtrigger20 after the cutting/stapling operation so that it can return to its original position, the user will experience a clockwise rotation force from the firingtrigger20 that is generally proportional to the reverse speed of themotor65.
• It should also be noted that in this embodiment the user can apply force (either in lieu of or in addition to the force from the motor65) to actuate the main drive shaft assembly (and hence the cutting/stapling operation of the end effector12) through retracting the firingtrigger20. That is, retracting the firingtrigger20 causes thegear portions206,208 to rotate counter clockwise, which causes the gears of thegear box assembly200 to rotate, thereby causing thepinion gear124 to rotate, which causes themain drive shaft48 to rotate.
• Although not shown inFIGS. 25-31, theinstrument10 may further include reverse motor and stop motor sensors. As described above, the reverse motor and stop motor sensors may detect, respectively, the end of the cutting stroke (full deployment of the knife32) and the end of retraction operation (full retraction of the knife32). A similar circuit to that described above in connection withFIG. 11 may be used to appropriately power themotor65.
• FIGS. 32-36 illustrate a two-stroke, motorized surgical cutting andfastening instrument10 with power assist according to another embodiment. The embodiment ofFIGS. 32-36 is similar to that ofFIGS. 25-31 except that in the embodiment ofFIGS. 32-36, the firingtrigger20 includes alower portion228 and anupper portion230. Bothportions228,230 are connected to and pivot about apivot pin207 that is disposed through eachportion228,230. Theupper portion230 includes agear portion232 that engages thefirst gear210 of thegear box assembly200. Thespring222 is connected to theupper portion230 such that the upper portion is biased to rotate in the clockwise direction. Theupper portion230 may also include alower arm234 that contacts an upper surface of thelower portion228 of the firingtrigger20 such that when theupper portion230 is caused to rotate clockwise thelower portion228 also rotates clockwise, and when thelower portion228 rotates counter clockwise theupper portion230 also rotates counter clockwise. Similarly, thelower portion228 includes arotational stop238 that engages a shoulder of theupper portion230. In that way, when theupper portion230 is caused to rotate counter clockwise thelower portion228 also rotates counter clockwise, and when thelower portion228 rotates clockwise theupper portion230 also rotates clockwise.
• The illustrated embodiment also includes therun motor sensor110 that communicates a signal to themotor65 that, in various embodiments, may cause themotor65 to rotate at a speed proportional to the force applied by the operator when retracting the firingtrigger20. Thesensor110 may be, for example, a rheostat or some other variable resistance sensor, as explained herein. In addition, theinstrument10 may includereverse motor sensor130 that is tripped or switched when contacted by afront face242 of theupper portion230 of the firingtrigger20. When activated, thereverse motor sensor130 sends a signal to themotor65 to reverse direction. Also, theinstrument10 may include astop motor sensor142 that is tripped or actuated when contacted by thelower portion228 of the firingtrigger20. When activated, thestop motor sensor142 sends a signal to stop the reverse rotation of themotor65.
• In operation, when an operator retracts theclosure trigger18 into the locked position, the firingtrigger20 is retracted slightly (through mechanisms known in the art, including U.S. Pat. No. 6,978,921 to Frederick Shelton, IV et. al and U.S. Pat. No. 6,905,057 to Jeffery S. Swayze et. al, which are incorporated herein by reference) so that the user can grasp the firingtrigger20 to initiate the cutting/stapling operation, as shown inFIGS. 32 and 33. At that point, as shown inFIG. 33, thegear portion232 of theupper portion230 of the firingtrigger20 moves into engagement with thefirst gear210 of thegear box assembly200. When the operator retracts the firingtrigger20, according to various embodiments, the firingtrigger20 may rotate a small amount, such as five degrees, before tripping therun motor sensor110, as shown inFIG. 34. Activation of thesensor110 causes themotor65 to forward rotate at a rate proportional to the retraction force applied by the operator. The forward rotation of themotor65 causes, as described above, themain drive shaft48 to rotate, which causes theknife32 in theend effector12 to be deployed (i.e., begin traversing the channel22). Rotation of thepinion gear124, which is connected to themain drive shaft48, causes the gears210-220 in thegear box assembly200 to rotate. Since thefirst gear210 is in engagement with thegear portion232 of theupper portion230 of the firingtrigger20, theupper portion232 is caused to rotate counter clockwise, which causes thelower portion228 to also rotate counter clockwise.
• When theknife32 is fully deployed (i.e., at the end of the cutting stroke), thefront face242 of theupper portion230 trips thereverse motor sensor130, which sends a signal to themotor65 to reverse rotational directional. This causes the main drive shaft assembly to reverse rotational direction to retract theknife32. Reverse rotation of the main drive shaft assembly also causes the gears210-220 in the gear box assembly to reverse direction, which causes theupper portion230 of the firingtrigger20 to rotate clockwise, which causes thelower portion228 of the firingtrigger20 to rotate clockwise until thelower portion228 trips or actuates thestop motor sensor142 when theknife32 is fully retracted, which causes themotor65 to stop. In that way, the user experiences feedback regarding deployment of theend effector12 by way of the user's grip on the firingtrigger20. Thus, when the user retracts the firingtrigger20, the operator will experience a resistance related to the deployment of theend effector12 and, in particular, to the loading force experienced by theknife32. Similarly, when the operator releases the firingtrigger20 after the cutting/stapling operation so that it can return to its original position, the user will experience a clockwise rotation force from the firingtrigger20 that is generally proportional to the reverse speed of themotor65.
• It should also be noted that in this embodiment the user can apply force (either in lieu of or in addition to the force from the motor65) to actuate the main drive shaft assembly (and hence the cutting/stapling operation of the end effector12) through retracting the firingtrigger20. That is, retracting the firingtrigger20 causes thegear portion232 of theupper portion230 to rotate counter clockwise, which causes the gears of thegear box assembly200 to rotate, thereby causing thepinion gear124 to rotate, which causes the main drive shaft assembly to rotate.
• The above-described embodiments employed power-assist user feedback systems, with or without adaptive control (e.g., using asensor110,130, and142 outside of the closed loop system of themotor65, gear drive train, and end effector12) for a two-stroke, motorized surgical cutting and fastening instrument. That is, force applied by the user in retracting the firingtrigger20 may be added to the force applied by themotor65 by virtue of the firingtrigger20 being geared into (either directly or indirectly) the gear drive train between themotor65 and themain drive shaft48. In other embodiments of the present invention, the user may be provided with tactile feedback regarding the position of theknife32 in the end effector, but without having the firingtrigger20 geared into the gear drive train.FIGS. 37-40 illustrate a motorized surgical cutting and fastening instrument with such a tactile position feedback system.
• In the illustrated embodiment ofFIGS. 37-40, the firingtrigger20 may have alower portion228 and anupper portion230, similar to theinstrument10 shown inFIGS. 32-36. Unlike the embodiment ofFIG. 32-36, however, theupper portion230 does not have a gear portion that mates with part of the gear drive train. Instead, the instrument includes asecond motor265 with a threadedrod266 threaded therein. The threadedrod266 reciprocates longitudinally in and out of themotor265 as themotor265 rotates, depending on the direction of rotation. Theinstrument10 also includes anencoder268 that is responsive to the rotations of themain drive shaft48 for translating the incremental angular motion of the main drive shaft48 (or other component of the main drive assembly) into a corresponding series of digital signals, for example. In the illustrated embodiment, thepinion gear124 includes aproximate drive shaft270 that connects to theencoder268.
• Theinstrument10 also includes a control circuit (not shown), which may be implemented using a microcontroller or some other type of integrated circuit, that receives the digital signals from theencoder268. Based on the signals from theencoder268, the control circuit may calculate the stage of deployment of theknife32 in theend effector12. That is, the control circuit can calculate if theknife32 is fully deployed, fully retracted, or at an intermittent stage. Based on the calculation of the stage of deployment of theend effector12, the control circuit may send a signal to thesecond motor265 to control its rotation to thereby control the reciprocating movement of the threadedrod266.
• In operation, as shown inFIG. 37, when theclosure trigger18 is not locked into the clamped position, the firingtrigger20 rotated away from thepistol grip portion26 of thehandle6 such that thefront face242 of theupper portion230 of the firingtrigger20 is not in contact with the proximate end of the threadedrod266. When the operator retracts theclosure trigger18 and locks it in the clamped position, the firingtrigger20 rotates slightly towards theclosure trigger20 so that the operator can grasp the firingtrigger20, as shown inFIG. 38. In this position, thefront face242 of theupper portion230 contacts the proximate end of the threadedrod266.
• As the user then retracts the firingtrigger20, after an initial rotational amount (e.g. 5 degrees of rotation) therun motor sensor110 may be activated such that, as explained above, thesensor110 sends a signal to themotor65 to cause it to rotate at a forward speed proportional to the amount of retraction force applied by the operator to the firingtrigger20. Forward rotation of themotor65 causes themain drive shaft48 to rotate via the gear drive train, which causes theknife32 andsled33 to travel down thechannel22 and sever tissue clamped in theend effector12. The control circuit receives the output signals from theencoder268 regarding the incremental rotations of the main drive shaft assembly and sends a signal to thesecond motor265 to cause thesecond motor265 to rotate, which causes the threadedrod266 to retract into themotor265. This allows theupper portion230 of the firingtrigger20 to rotate counter clockwise, which allows thelower portion228 of the firing trigger to also rotate counter clockwise. In that way, because the reciprocating movement of the threadedrod266 is related to the rotations of the main drive shaft assembly, the operator of theinstrument10, by way of his/her grip on the firingtrigger20, experiences tactile feedback as to the position of theend effector12. The retraction force applied by the operator, however, does not directly affect the drive of the main drive shaft assembly because the firingtrigger20 is not geared into the gear drive train in this embodiment.
• By virtue of tracking the incremental rotations of the main drive shaft assembly via the output signals from theencoder268, the control circuit can calculate when theknife32 is fully deployed (i.e., fully extended). At this point, the control circuit may send a signal to themotor65 to reverse direction to cause retraction of theknife32. The reverse direction of themotor65 causes the rotation of the main drive shaft assembly to reverse direction, which is also detected by theencoder268. Based on the reverse rotation detected by theencoder268, the control circuit sends a signal to thesecond motor265 to cause it to reverse rotational direction such that the threadedrod266 starts to extend longitudinally from themotor265. This motion forces theupper portion230 of the firingtrigger20 to rotate clockwise, which causes thelower portion228 to rotate clockwise. In that way, the operator may experience a clockwise force from the firingtrigger20, which provides feedback to the operator as to the retraction position of theknife32 in theend effector12. The control circuit can determine when theknife32 is fully retracted. At this point, the control circuit may send a signal to themotor65 to stop rotation.
• According to other embodiments, rather than having the control circuit determine the position of theknife32, reverse motor and stop motor sensors may be used, as described above. In addition, rather than using aproportional sensor110 to control the rotation of themotor65, an on/off switch or sensor can be used. In such an embodiment, the operator would not be able to control the rate of rotation of themotor65. Rather, it would rotate at a preprogrammed rate.
• FIGS. 41-43 illustrate an exemplary embodiment of a mechanically actuated endocutter, and in particular thehandle6,shaft8 and endeffector12 thereof. Further details of a mechanically actuated endocutter may be found in U.S. patent application Ser. No. 11/052,632 entitled, “Surgical Stapling Instrument Incorporating A Multi-Stroke Firing Mechanism With Automatic End Of Firing Travel Retraction,” which is incorporated herein by reference. With reference toFIG. 41, theend effector12 responds to the closure motion from the handle6 (not depicted inFIG. 41) first by including ananvil face1002 connecting to an anvilproximal end1004 that includes laterally projecting anvil pivot pins25 that are proximal to a vertically projectinganvil tab27. The anvil pivot pins25 translate within kidney shapedopenings1006 in thestaple channel22 to open andclose anvil24 relative to channel22. Thetab27 engages abent tab1007 extending inwardly in tab opening45 on adistal end1008 of theclosure tube1005, the latter distally terminating in adistal edge1008 that pushes against theanvil face1002. Thus, when theclosure tube1005 moves proximally from its open position, thebent tab1007 of theclosure tube1005 draws theanvil tab27 proximally, and the anvil pivot pins25 follow the kidney shapedopenings1006 of thestaple channel22 causing theanvil24 to simultaneously translate proximally and rotate upward to the open position. When theclosure tube1005 moves distally, thebent tab1007 in thetab opening45 releases from theanvil tab27 and thedistal edge1008 pushes on theanvil face1002, closing theanvil24.
• With continued reference toFIG. 41, theshaft8 and endeffector12 also include components that respond to a firing motion of afiring rod1010. In particular, thefiring rod1010 rotatably engages afiring trough member1012 having alongitudinal recess1014.Firing trough member1012 moves longitudinally withinframe1016 in direct response to longitudinal motion of firingrod1010. Alongitudinal slot1018 in theclosure tube1005 operably couples with the right and left exterior side handlepieces61,62 of the handle6 (not shown inFIG. 41). The length of thelongitudinal slot1018 in theclosure tube1005 is sufficiently long to allow relative longitudinal motion with thehandle pieces61,62 to accomplish firing and closure motions respectively with the coupling of thehandle pieces61,62 passing on through a longitudinal slot1020 in theframe1016 to slidingly engage thelongitudinal recess1014 in theframe trough member1012.
• The distal end of theframe trough member1012 is attached to a proximal end of afiring bar1022 that moves within theframe1016, specifically within aguide1024 therein, to distally project theknife32 into theend effector12. Theend effector12 includes astaple cartridge34 that is actuated by theknife32. Thestaple cartridge34 has atray1028 that holds astaple cartridge body1030, awedge sled driver33,staple drivers1034 andstaples1036. It will be appreciated that thewedge sled driver33 longitudinally moves within a firing recess (not shown) located between thecartridge tray1028 and thecartridge body1030. Thewedge sled driver33 presents camming surfaces that contact and lift thestaple drivers1034 upward, driving thestaples1036. Thestaple cartridge body1030 further includes a proximally open,vertical slot1031 for passage of theknife32. Specifically, a cutting surface1027 is provided along a distal end ofknife32 to cut tissue after it is stapled.
• It should be appreciated that theshaft8 is shown inFIG. 4 as a non-articulating shaft. Nonetheless, applications of the present invention may include instruments capable of articulation, for example, as such shown above with reference toFIGS. 1-4 and described in the following U.S. patents and patent applications, the disclosure of each being hereby incorporated by reference in their entirety: (1) “SURGICAL INSTRUMENT INCORPORATING AN ARTICULATION MECHANISM HAVING ROTATION ABOUT THE LONGITUDINAL AXIS”, U.S. Patent Application Publication No. 2005/0006434, by Frederick E. Shelton IV, Brian J. Hemmelgam, Jeffrey S. Swayze, Kenneth S. Wales, filed 9 Jul. 2003; (2) “SURGICAL STAPLING INSTRUMENT INCORPORATING AN ARTICULATION JOINT FOR A FIRING BAR TRACK”, U.S. Pat. No. 6,786,382, to Brian J. Hemmelgam; (3) “A SURGICAL INSTRUMENT WITH A LATERAL-MOVING ARTICULATION CONTROL”, U.S. Pat. No. 6,981,628, to Jeffrey S. Swayze; (4) “SURGICAL STAPLING INSTRUMENT INCORPORATING A TAPERED FIRING BAR FOR INCREASED FLEXIBILITY AROUND THE ARTICULATION JOINT”, U.S. Pat. No. 6,964,363, to Frederick E. Shelton IV, Michael Setser, Bruce Weisenburgh II; and (5) “SURGICAL STAPLING INSTRUMENT HAVING ARTICULATION JOINT SUPPORT PLATES FOR SUPPORTING A FIRING BAR”, U.S. Patent Application Publication No. 2005/0006431, by Jeffrey S. Swayze, Joseph Charles Hueil, filed 9 Jul. 2003.
• FIGS. 42-43 show an embodiment of thehandle6 that is configured for use in a mechanically actuated endocutter along with the embodiment of theshaft8 and endeffector12 as shown above inFIG. 41. It will be appreciated that any suitable handle design may be used to mechanically close and fire theend effector12. InFIGS. 42-43, thehandle6 of the surgical stapling and severinginstrument10 includes a linkedtransmission firing mechanism1060 that provides features such as increased strength, reduced handle size, minimized binding, etc.
• Closure of the end effector12 (not shown inFIGS. 42-43) is caused by depressing theclosure trigger18 toward thepistol grip26 ofhandle6. Theclosure trigger18 pivots about aclosure pivot pin252 that is coupled to right and left exteriorlower side pieces59,60 thehandle6, causing anupper portion1094 of theclosure trigger18 to move forward. Theclosure tube1005 receives this closure movement via theclosure yoke250 that is pinned to a closure link1042 and to theupper portion1094 of theclosure trigger18 respectively by aclosure yoke pin1044 and aclosure link pin1046.
• In the fully open position ofFIG. 42, theupper portion1094 of theclosure trigger18 contacts and holds alocking arm1048 of the pivotingclosure release button30 in the position shown. When theclosure trigger18 reaches its fully depressed position, theclosure trigger18 releases thelocking arm1048 and anabutting surface1050 rotates into engagement with a distalrightward notch1052 of thepivoting locking arm1048, holding theclosure trigger18 in this clamped or closed position. A proximal end of thelocking arm1048 pivots about a lateralpivotal connection1054 with thepieces59,60 to expose theclosure release button30. An intermediate,distal side1056 of theclosure release button30 is urged proximally by acompression spring1058, which is compressed between ahousing structure1040 andclosure release button30. The result is that theclosure release button30 urges thelocking arm1048 counterclockwise (when viewed from the left) into locking contact with the abuttingsurface1050 ofclosure trigger18, which prevents unclamping ofclosure trigger18 when the linkedtransmission firing system1040 is in an un-retracted condition.
• With theclosure trigger18 retracted and fully depressed, the firingtrigger20 is unlocked and may be depressed toward thepistol grip26, multiple times in this embodiment, to effect firing of theend effector12. As depicted, the linkedtransmission firing mechanism1060 is initially retracted, urged to remain in this position by a combination tension/compression spring1062 that is constrained within thepistol grip26 of thehandle6, with itsnonmoving end1063 connected to thepieces59,60 and a movingend1064 connected to a downwardly flexed and proximal, retractedend1067 of asteel band1066.
• A distally-disposedend1068 of thesteel band1066 is attached to alink coupling1070 for structural loading, which in turn is attached to afront link1072aof a plurality of links1072a-1072dthat form a linkedrack1074. Linkedrack1074 is flexible yet has distal links that form a straight rigid rack assembly that may transfer a significant firing force through thefiring rod1010 in theshaft6, yet readily retract into thepistol grip26 to minimize the longitudinal length of thehandle6. It should be appreciated that the combination tension/compression spring1062 increases the amount of firing travel available while essentially reducing the minimum length by half over a single spring.
• The firingtrigger20 pivots about afiring trigger pin96 that is connected to thehandle pieces59,60. Anupper portion228 of the firingtrigger20 moves distally about the firingtrigger pin96 as the firingtrigger20 is depressed towardspistol grip26, stretching a proximally placed firingtrigger tension spring222 proximally connected between theupper portion228 of the firingtrigger20 and thepieces59,60. Theupper portion228 of the firingtrigger20 engages the linkedrack1074 during each firing trigger depression by atraction biasing mechanism1078 that also disengages when the firingtrigger20 is released. Firingtrigger tension spring222 urges the firingtrigger20 distally when released and disengages thetraction biasing mechanism1078.
• As the linkedtransmission firing mechanism1040 actuates, anidler gear1080 is rotated clockwise (as viewed from the left side) by engagement with a toothedupper surface1082 of the linkedrack1074. This rotation is coupled to anindicator gear1084, which thus rotates counterclockwise in response to theidler gear1080. Both theidler gear1080 andindicator gear1084 are rotatably connected to thepieces59,60 of thehandle6. The gear relationship between the linkedrack1074,idler gear1080 andindicator gear1084 may be advantageously selected so that the toothedupper surface1082 has tooth dimensions that are suitably strong and that theindicator gear1084 makes no more than one revolution during the full firing travel of the linkedtransmission firing mechanism1060.
• As described in greater detail below, theindicator gear1084 performs at least four functions. First, when the linkedrack1074 is fully retracted and bothtriggers18, are open as shown inFIG. 42, anopening1086 in acircular ridge1088 on the left side of theindicator gear1084 is presented to anupper surface1090 of thelocking arm1048.Locking arm1048 is biased into theopening1086 by contact with theclosure trigger18, which in turn is urged to the open position by aclosure tension spring1092. Closuretrigger tension spring1092 is connected proximally to theupper portion1094 of theclosure trigger18 and thehandle pieces59,60, and thus has energy stored during closing of theclosure trigger18 that urges theclosure trigger18 distally to its unclosed position.
• A second function of theindicator gear1084 is that it is connected to the indicatingretraction knob1096 externally disposed on thehandle6. Thus, theindicator gear1084 communicates the relative position of thefiring mechanism1060 to the indicatingretraction knob1096 so that the surgeon has a visual indication of how many strokes of the firingtrigger20 are required to complete firing.
• A third function of theindicator gear1084 is to longitudinally and angularly move ananti-backup release lever1098 of an anti-backup mechanism (one-way clutch mechanism)1097 as the surgical stapling and severinginstrument10 is operated. During the firing strokes, proximal movement ofanti-backup release lever1098 byindicator gear1084 activates theanti-backup mechanism1097 that allows distal movement of firingbar1010 and prevents proximal motion of firingbar1010. This movement also extends theanti-backup release button1100 from the proximal end of thehandle pieces59,60 for the operator to actuate should the need arise for the linkedtransmission firing mechanism1060 to be retracted during the firing strokes. After completion of the firing strokes, theindicator gear1084 reverses direction of rotation as thefiring mechanism1060 retracts. The reversed rotation deactivates theanti-backup mechanism1097, withdraws theanti-backup release button1100 into thehandle6, and rotates theanti-backup release lever1098 laterally to the right to allow continued reverse rotation of theindicator gear1084.
• A fourth function of theindicator gear1084 is to receive a manual rotation from the indicating retraction knob1096 (clockwise in the depiction ofFIG. 42) to retract thefiring mechanism1060 withanti-backup mechanism1097 unlocked, thereby overcoming any binding in thefiring mechanism1060 that is not readily overcome by the combination tension/compression spring1062. This manual retraction assistance may be employed after a partial firing of thefiring mechanism1060 that would otherwise be prevented by theanti-backup mechanism1097 that withdraws theanti-backup release button1100 so that the latter may not laterally move theanti-backup release lever1098.
• Continuing withFIGS. 42-43,anti-backup mechanism1097 consists of the operator accessibleanti-backup release lever1098 operably coupled at the proximal end to theanti-backup release button1100 and at the distal end to ananti-backup yoke1102. In particular, adistal end1099 of theanti-backup release lever1098 is engaged to theanti-backup yoke1102 by ananti-backup yoke pin1104. Theanti-backup yoke1102 moves longitudinally to impart a rotation to an anti-backupcam slot tube1106 that is longitudinally constrained by thehandle pieces59,90 and that encompasses thefiring rod1010 distally to the connection of thefiring rod1010 to thelink coupling1070 of the linkedrack1074. Theanti-backup yoke1102 communicates the longitudinal movement from theanti-backup release lever1098 via a camslot tube pin1108 to the anti-backupcam slot tube1106. That is, longitudinal movement of camslot tube pin1108 in an angled slot in the anti-backupcam slot tube1106 rotates the anti-backupcam slot tube1106.
• Trapped between a proximal end of theframe1016 and the anti-backupcam slot tube1106 respectively are ananti-backup compression spring1110, ananti-backup plate1112, and ananti-backup cam tube1114. As depicted, proximal movement of thefiring rod1010 causes theanti-backup plate1112 to pivot top to the rear, presenting an increased frictional contact to thefiring rod1010 that resists further proximal movement of thefiring rod1010.
• Thisanti-backup plate1112 pivots in a manner similar to that of a screen door lock that holds open a screen door when the anti-backupcam slot tube1106 is closely spaced to theanti-backup cam tube1114. Specifically, theanti-backup compression spring1110 is able to act upon a top surface of theplate1112 to tip theanti-backup plate1112 to its locked position. Rotation of the anti-backupcam slot tube1106 causes a distal camming movement of theanti-backup cam tube1114 thereby forcing the top of theanti-backup plate1112 distally, overcoming the force from theanti-backup compression spring1110, thus positioning theanti-backup plate1112 in an untipped (perpendicular), unlocked position that allows proximal retraction of thefiring rod1010.
• With particular reference toFIG. 43, thetraction biasing mechanism1078 is depicted as being composed of apawl1116 that has a distally projectingnarrow tip1118 and a rightwardly projectinglateral pin1120 at its proximal end that is rotatably inserted through ahole1076 in theupper portion230 of the firingtrigger20. On the right side of the firingtrigger20 thelateral pin1120 receives a biasing member, depicted asbiasing wheel1122. As the firingtrigger20 translates fore and aft, thebiasing wheel1122 traverses an arc proximate to theright half piece59 of thehandle6, overrunning at its distal portion of travel abiasing ramp1124 integrally formed in theright half piece59. Thebiasing wheel1122 may advantageously be formed from a resilient, frictional material that induces a counterclockwise rotation (when viewed from the left) into thelateral pin1120 of thepawl1116, thus traction biasing the distally projectingnarrow tip1118 downward into a rampedcentral track1075 of the nearest link1072a-dto engage the linkedrack1074.
• As the firingtrigger20 is released, thebiasing wheel1122 thus fractionally biases thepawl1116 in the opposite direction, raising thenarrow tip1118 from the rampedcentral track1075 of the linkedrack1074. To ensure disengagement of thetip1118 under high load conditions and at nearly full distal travel of thepawl1116, the right side of thepawl1116 ramps up onto a proximally and upwardly facingbeveled surface1126 on the rightside of theclosure yoke250 to disengage thenarrow tip1118 from the rampedcentral track1075. If the firingtrigger20 is released at any point other than full travel, thebiasing wheel1122 is used to lift thenarrow tip1118 from the rampedcentral track1075. Whereas abiasing wheel1122 is depicted, it should be appreciated that the shape of the biasing member orwheel1122 is illustrative and may be varied to accommodate a variety of shapes that use friction or traction to engage or disengage the firing of theend effector12.
• Various embodiments of thesurgical instrument10 have the capability to record instrument conditions at one or more times during use.FIG. 44 shows a block diagram of asystem2000 for recording conditions of theinstrument10. It will be appreciated that thesystem2000 may be implemented in embodiments of theinstrument10 having motorized or motor-assisted firing, for example, as described above with reference toFIGS. 1-40, as well as embodiments of theinstrument10 having mechanically actuated firing, for example, as described above with reference toFIGS. 41-43.
• Thesystem2000 may includevarious sensors2002,2004,2006,2008,2010,2012 for sensing instrument conditions. The sensors may be positioned, for example, on or within theinstrument10. In various embodiments, the sensors may be dedicated sensors that provide output only for thesystem2000, or may be dual-use sensors that perform other functions with in theinstrument10. For example,sensors110,130,142 described above may be configured to also provide output to thesystem2000.
• Directly or indirectly, each sensor provides a signal to thememory device2001, which records the signals as described in more detail below. Thememory device2001 may be any kind of device capable of storing or recording sensor signals. For example, thememory device2001 may include a microprocessor, an Electrically Erasable Programmable Read Only Memory (EEPROM), or any other suitable storage device. Thememory device2001 may record the signals provided by the sensors in any suitable way. For example, in one embodiment, thememory device2001 may record the signal from a particular sensor when that signal changes states. In another embodiment, thememory device2001 may record a state of thesystem2000, e.g., the signals from all of the sensors included in thesystem2000, when the signal from any sensor changes states. This may provide a snap-shot of the state of theinstrument10. In various embodiments, thememory device2001 and/or sensors may be implemented to include 1-WIRE bus products available from DALLAS SEMICONDUCTOR such as, for example, a 1-WIRE EEPROM.
• In various embodiments, thememory device2001 is externally accessible, allowing an outside device, such as a computer, to access the instrument conditions recorded by thememory device2001. For example, thememory device2001 may include adata port2020. Thedata port2020 may provide the stored instrument conditions according to any wired or wireless communication protocol in, for example, serial or parallel format. Thememory device2001 may also include a removable medium2021 in addition to or instead of theoutput port2020. The removable medium2021 may be any kind of suitable data storage device that can be removed from theinstrument10. For example, the removable medium2021 may include any suitable kind of flash memory, such as a Personal Computer Memory Card International Association (PCMCIA) card, a COMPACTFLASH card, a MULTIMEDIA card, a FLASHMEDIA card, etc. The removable medium2021 may also include any suitable kind of disk-based storage including, for example, a portable hard drive, a compact disk (CD), a digital video disk (DVD), etc.
• Theclosure trigger sensor2002 senses a condition of theclosure trigger18.FIGS. 45 and 46 show an exemplary embodiment of theclosure trigger sensor2002. InFIGS. 45 and 46, theclosure trigger sensor2002 is positioned between theclosure trigger18 andclosure pivot pin252. It will be appreciated that pulling theclosure trigger18 toward thepistol grip26 causes theclosure trigger18 to exert a force on theclosure pivot pin252. Thesensor2002 may be sensitive to this force, and generate a signal in response thereto, for example, as described above with respect tosensor110 andFIGS. 10A and 10B. In various embodiments, theclosure trigger sensor2002 may be a digital sensor that indicates only whether theclosure trigger18 is actuated or not actuated. In other various embodiments, theclosure trigger sensor2002 may be an analog sensor that indicates the force exerted on theclosure trigger18 and/or the position of theclosure trigger18. If theclosure trigger sensor2002 is an analog sensor, an analog-to-digital converter may be logically positioned between thesensor2002 and thememory device2001. Also, it will be appreciated that theclosure trigger sensor2002 may take any suitable form and be placed at any suitable location that allows sensing of the condition of the closure trigger.
• Theanvil closure sensor2004 may sense whether theanvil24 is closed.FIG. 47 shows an exemplaryanvil closure sensor2004. Thesensor2004 is positioned next to, or within the kidney shapedopenings1006 of thestaple channel22 as shown. As theanvil24 is closed, anvil pivot pins25 slides through the kidney shapedopenings1006 and into contact with thesensor2004, causing thesensor2004 to generate a signal indicating that theanvil24 is closed. Thesensor2004 may be any suitable kind of digital or analog sensor including a proximity sensor, etc. It will be appreciated that when theanvil closure sensor2004 is an analog sensor, an analog-to-digital converter may be included logically between thesensor2004 and thememory device2001.
• Anvilclosure load sensor2006 is shown placed on an inside bottom surface of thestaple channel22. In use, thesensor2006 may be in contact with a bottom side of the staple cartridge34 (not shown inFIG. 46). As theanvil24 is closed, it exerts a force on thestaple cartridge34 which is transferred to thesensor2006. In response, thesensor2006 generates a signal. The signal may be an analog signal proportional to the force exerted on thesensor2006 by thestaple cartridge34 and due to the closing of theanvil24. Referring theFIG. 44, the analog signal may be provided to an analog-to-digital converter2014, which converts the analog signal to a digital signal before providing it to thememory device2001. It will be appreciated that embodiments where thesensor2006 is a digital or binary sensor may not include analog-to-digital converter2014.
• The firingtrigger sensor110 senses the position and/or state of the firingtrigger20. In motorized or motor-assisted embodiments of the instrument, the firing trigger sensor may double as therun motor sensor110 described above. In addition, the firingtrigger sensor110 may take any of the forms described above, and may be analog or digital.FIGS. 45 and 46 show an additional embodiment of the firingtrigger sensor110. InFIGS. 45 and 46, the firing trigger sensor is mounted between firingtrigger20 and firingtrigger pivot pin96. When firingtrigger20 is pulled, it will exert a force on firingtrigger pivot pin96 that is sensed by thesensor110. Referring toFIG. 44, In embodiments where the output of the firingtrigger sensor110 is analog, analog-to-digital converter2016 is included logically between the firingtrigger sensor110 and thememory device2001.
• Theknife position sensor2008 senses the position of theknife32 or cutting surface1027 within thestaple channel22.FIGS. 47 and 48 show embodiments of aknife position sensor2008 that are suitable for use with the mechanically actuatedshaft8 and endeffector12 shown inFIG. 41. Thesensor2008 includes amagnet2009 coupled to thefiring bar1022 of theinstrument10. Acoil2011 is positioned around thefiring bar1022, and may be installed; for example, along thelongitudinal recess1014 of the firing trough member1012 (seeFIG. 41). As theknife32 and cutting surface1027 are reciprocated through thestaple channel22, thefiring bar1022 andmagnet2009 may move back and forth through thecoil2011. This motion relative to the coil induces a voltage in the coil proportional to the position of the firing rod within the coil and the cutting edge1027 within thestaple channel22. This voltage may be provided to thememory device2001, for example, via analog-to-digital converter2018.
• In various embodiments, theknife position sensor2008 may instead be implemented as a series of digital sensors (not shown) placed at various positions on or within theshaft8. The digital sensors may sense a feature of thefiring bar1022 such as, for example,magnet2009, as the feature reciprocates through theshaft8. The position of thefiring bar1022 within theshaft8, and by extension, the position of theknife32 within thestaple channel22, may be approximated as the position of the last digital sensor tripped.
• It will be appreciated that the knife position may also be sensed in embodiments of theinstrument10 having a rotary drivenend effector12 andshaft8, for example, as described above, with reference toFIGS. 3-6. An encoder, such asencoder268, may be configured to generate a signal proportional to the rotation of thehelical screw shaft36, or any other drive shaft or gear. Because the rotation of theshaft36 and other drive shafts and gears is proportional to the movement of theknife32 through thechannel22, the signal generated by theencoder268 is also proportional to the movement of theknife32. Thus, the output of theencoder268 may be provided to thememory device2001.
• The cartridgepresent sensor2010 may sense the presence of thestaple cartridge34 within thestaple channel22. In motorized or motor-assisted instruments, the cartridgepresent sensor2010 may double as the cartridge lock-out sensor136 described above with reference toFIG. 11.FIGS. 50 and 51 show an embodiment of the cartridgepresent sensor2010. In the embodiment shown, the cartridgepresent sensor2010 includes two contacts,2011 and2013. When nocartridge34 is present, thecontacts2011,2013 form an open circuit. When acartridge34 is present, thecartridge tray1028 of thestaple cartridge34 contacts thecontacts2011,2013, a closed circuit is formed. When the circuit is open, thesensor2010 may output a logic zero. When the circuit is closed, thesensor2010 may output a logic one. The output of thesensor2010 is provided tomemory device2001, as shown inFIG. 44.
• Thecartridge condition sensor2012 may indicate whether acartridge34 installed within thestaple channel22 has been fired or spent. As theknife32 is translated through theend effector12, it pushes thesled33, which fires the staple cartridge. Then theknife32 is translated back to its original position, leaving thesled33 at the distal end of the cartridge. Without thesled33 to guide it, theknife32 may fall into lock-outpocket2022.Sensor2012 may sense whether theknife32 is present in the lock-outpocket2022, which indirectly indicates whether thecartridge34 has been spent. It will be appreciated that in various embodiments,sensor2012 may directly sense the present of the sled at the proximate end of thecartridge34, thus eliminating the need for theknife32 to fall into the lock-outpocket2022.
• FIGS. 52A and 52B depict aprocess flow2200 for operating embodiments of thesurgical instrument10 configured as an endocutter and having the capability to record instrument conditions according to various embodiments. Atbox2202, theanvil24 of theinstrument10 may be closed. This causes theclosure trigger sensor2002 and or theanvil closure sensor2006 to change state. In response, thememory device2001 may record the state of all of the sensors in thesystem2000 atbox2203. Atbox2204, theinstrument10 may be inserted into a patient. When the instrument is inserted, theanvil24 may be opened and closed atbox2206, for example, to manipulate tissue at the surgical site. Each opening and closing of theanvil24 causes theclosure trigger sensor2002 and/or theanvil closure sensor2004 to change state. In response, thememory device2001 records the state of thesystem2000 atbox2205.
• Atbox2208, tissue is clamped for cutting and stapling. If theanvil24 is not closed atdecision block2210, continued clamping is required. If theanvil24 is closed, then thesensors2002,2004 and/or2006 may change state, prompting thememory device2001 to record the state of the system atbox2213. This recording may include a closure pressure received fromsensor2006. Atbox2212, cutting and stapling may occur.Firing trigger sensor110 may change state as the firingtrigger20 is pulled toward thepistol grip26. Also, as theknife32 moves through thestaple channel22,knife position sensor2008 will change state. In response, thememory device2001 may record the state of thesystem2000 atbox2013.
• When the cutting and stapling operations are complete, theknife32 may return to a pre-firing position. Because thecartridge34 has now been fired, theknife32 may fall into lock-outpocket2022, changing the state ofcartridge condition sensor2012 and triggering thememory device2001 to record the state of thesystem2000 at box2015. Theanvil24 may then be opened to clear the tissue. This may cause one or more of theclosure trigger sensor2002,anvil closure sensor2004 and anvilclosure load sensor2006 to change state, resulting in a recordation of the state of thesystem2000 at box2017. After the tissue is cleared, theanvil24 may be again closed atbox2220. This causes another state change for at leastsensors2002 and2004, which in turn causes thememory device2001 to record the state of the system at box2019. Then theinstrument10 may be removed from the patient atbox2222.
• If theinstrument10 is to be used again during the same procedure, the anvil may be opened atbox2224, triggering another recordation of the system state atbox2223. The spentcartridge34 may be removed from theend effector12 atbox2226. This causes cartridgepresent sensor2010 to change state and cause a recordation of the system state atbox2225. Anothercartridge34 may be inserted atbox2228. This causes a state change in the cartridgepresent sensor2010 and a recordation of the system state atbox2227. If theother cartridge34 is a new cartridge, indicated atdecision block2230, its insertion may also cause a state change tocartridge condition sensor2012. In that case, the system state may be recorded atbox2231.
• FIG. 53 shows anexemplary memory map2300 from thememory device2001 according to various embodiments. Thememory map2300 includes a series ofcolumns2302,2304,2306,2308,2310,2312,2314,2316 and rows (not labeled).Column2302 shows an event number for each of the rows. The other columns represent the output of one sensor of thesystem2000. All of the sensor readings recorded at a given time may be recorded in the same row under the same event number. Hence, each row represents an instance where one or more of the signals from the sensors of thesystem2000 are recorded.
• Column2304 lists the closure load recorded at each event. This may reflect the output of anvilclosure load sensor2006.Column2306 lists the firing stroke position. This may be derived from theknife position sensor2008. For example, the total travel of theknife32 may be divided into partitions. The number listed incolumn2306 may represent the partition where theknife32 is currently present. The firing load is listed incolumn2308. This may be derived from the firingtrigger sensor110. The knife position is listed atcolumn2310. The knife position may be derived from theknife position sensor2008 similar to the firing stroke. Whether theanvil24 is open or closed may be listed atcolumn2312. This value may be derived from the output of theanvil closure sensor2004 and/or the anvilclosure load sensor2006. Whether thesled33 is present, or whether thecartridge34 is spent, may be indicated atcolumn2314. This value may be derived from thecartridge condition sensor2012. Finally, whether thecartridge34 is present may be indicated acolumn2316. This value may be derived from cartridgepresent sensor2010. It will be appreciated that various other values may be stored atmemory device2001 including, for example, the end and beginning of firing strokes, for example, as measured bysensors130,142.
• While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.
• For example, although the embodiments described above have advantages for an endoscopically employed surgical severing and staplinginstrument100, a similar embodiments may be used in other clinical procedures. It is generally accepted that endoscopic procedures are more common than laparoscopic procedures. Accordingly, the present invention has been discussed in terms of endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic”, should not be construed to limit the present invention to a surgical instrument for use only in conjunction with an endoscopic tube (i.e., trocar). On the contrary, it is believed that the present invention may find use in any procedure where access is limited to a small incision, including but not limited to laparoscopic procedures, as well as open procedures.
• Any patent, publication, or information, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this document. As such the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference.

Claims (17)

1-20. (canceled)

21. A surgical tool system, comprising:

a surgical tool operable to staple tissue, the tool comprising:

a distal portion including a tissue stapling mechanism;

a shaft extending from the distal portion; and

a handle;

a sensor coupled to the surgical tool;

a control system electrically connected to the sensor, wherein the control system calculates sensor information from signals received from the sensor and processes the sensor information into signal commands; and

a feedback system including a force actuator coupled to the handle and electrically connected to the control system, wherein the control system communicates the signal commands to the feedback system and the feedback system uses the signal commands to generate feedback relating to the sensor information to the handle.

22. The surgical tool system ofclaim 21, wherein the tissue stapling mechanism is selectively attachable to the shaft.

23. The surgical tool system ofclaim 21, further comprising a firing member configured to operate the tissue stapling mechanism, wherein the handle further comprises:

a motor configured to operate the firing member; and

a trigger configured to operate the motor, wherein the force actuator is configured to apply the feedback to the trigger.

24. The surgical tool system ofclaim 21, further comprising a cutting element on the distal portion of the tool, wherein the sensor comprises a displacement sensor configured to detect the stroke of the cutting element, and wherein the feedback generated by the feedback system informs a user of the position of the cutting element.

25. The surgical tool system ofclaim 24, wherein the feedback generated by the feedback system informs a user upon the completion of the cutting element stroke.

26. The surgical tool system ofclaim 24, wherein the cutting member comprises at least a portion of the displacement sensor coupled thereto.

27. The surgical tool system ofclaim 21, wherein the tissue stapling mechanism comprises a staple cartridge and an anvil, wherein the anvil is configured to be moved between an open position and a closed position to apply pressure to a patient's tissue positioned between the anvil and the staple cartridge, wherein the sensor comprises a pressure sensor, and wherein the control system is configured to monitor the pressure applied to the tissue as indicated by the pressure sensor.

28. The surgical tool system ofclaim 21, wherein the sensor is coupled to the distal portion of the tool and is selected from the group consisting of a pressure sensor and a displacement sensor, and wherein the feedback generated by the feedback system informs a user of the condition of the distal portion of the tool.

29. The surgical tool system ofclaim 21, wherein the sensor is coupled to the distal portion of the tool and is selected from the group consisting of a pressure sensor and a displacement sensor, and wherein the feedback generated by the feedback system informs a user that tissue positioned within the tissue stapling mechanism has been completely incised.

30. The surgical tool system ofclaim 21, wherein the tissue stapling mechanism comprises a staple cartridge and an anvil, wherein the anvil is configured to be moved between an open position and a closed position to apply pressure to a patient's tissue positioned between the anvil and the staple cartridge, and wherein the feedback generated by the feedback system informs a user that tissue positioned within the tissue stapling mechanism has been completely incised.

31. The surgical tool system ofclaim 21, wherein the feedback generated by the feedback system informs a user of the surgical tool system that a stapling procedure has been completed.

32. A method of providing feedback to a user during a tissue stapling procedure, the method comprising the steps of:

monitoring a distal portion of a surgical tool during a tissue stapling surgical procedure via at least one sensor mounted on the distal portion of the surgical tool;

processing the sensor information; and

communicating tactile feedback to a handle of the surgical tool, wherein the tactile feedback relates to the sensor information.

33. The method ofclaim 32, further comprising the steps of:

monitoring displacement of a cutting element on the distal portion of the surgical tool during the tissue stapling surgical procedure;

processing the displacement information; and

communicating tactile feedback to the handle of the surgical tool, wherein the tactile feedback relates to the displacement information and informs the user of the position of the cutting element.

34. The method ofclaim 33, wherein the tactile feedback generated by the feedback system informs the user upon completion of the stapling procedure.

35. A surgical tool system, comprising:

a surgical tool operable to staple tissue, the tool including a distal portion including a tissue stapling mechanism connected to a handle via a shaft;

a sensor coupled to the surgical tool;

a control system electrically connected to the sensor, wherein the control system calculates sensor information from signals received from the sensor and processes the sensor information into signal commands; and

a feedback system including a tactile actuator coupled to the handle and electrically connected to the control system, wherein the control system communicates the signal commands to the feedback system and the feedback system uses the signal commands to generate tactile feedback relating to the sensor information to the handle.

36. A surgical stapler, comprising:

a handle;

a sensor;

a control system electrically connected to the sensor, wherein the control system calculates sensor information from signals received from the sensor and processes the sensor information into signal commands; and

a feedback system including a force actuator coupled to the handle and electrically connected to the control system, wherein the control system communicates the signal commands to the feedback system and the feedback system uses the signal commands to generate force feedback relating to the sensor information to the handle.

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